Primary Business Status – Definitions

compliance.

a collaborative framework through which TPD notifications and testing can be completed

primary business status - definitions

Vendor / Distributor

A vendor is any business or sole trader engaged in the sale of vaping devices, e-liquid and accessories. This can be through dedicated premises, concession stand, or through e-commerce. Dependent on additional activities a vendor might also be considered a producer, which entails additional obligations under the Tobacco and Related Products Regulations (2016), and General Product Safety Regulations (2005). Under General Product Safety Regulations, a vendor is referred to as a distributor, and is defined as a professional in the supply chain whose activities do not affect the safety of the product. A vendor/distributor cannot manufacture or import products without taking the responsibilities of the producer.

A distributor’s responsibilities under General Product Safety Regulations are that they should act with due care and must not supply products which as a professional he knows or should have presumed to be dangerous. They should maintain records, as far as possible, to enable unsafe products to be traced back to their origins. This is only applicable within the limits of his activity. The requirement could be viewed as an obligation for a distributor to maintain the chain that enables tracing of products.

It should be noted that enforcement action by an enforcement authority concerning the maintenance of records would only be contemplated if there is a safety issue with the product.

Under the Tobacco and Related Products Regulations no additional constraints are placed on vendors/distributors beyond the restrictions of selling compliant product that has been duly notified by the producer.

Manufacturer / Importer / Producer

A producer, whether a business or a sole trader, takes additional responsibilities under both General Product Safety Regulations and Tobacco and Related Products Regulations. A producer is defined as:

  • The manufacturer of a product who is established in the EU;
  • A person established in the EU, holding himself out as the manufacturer, for example by selling private label products under his own brand ("own-branders");
  • A person established in the EU who reconditions the product;
  • A person established in the EU who represents a manufacturer from outside the EU;
  • Where there is no EU representative of the manufacturer, the importer into the EU;
  • Other professionals in the supply chain who affect the safety of the product.

Under General Product Safety Regulations, the producer is specifically required to:

  • Provide information to enable consumers to assess the risks inherent with the product (if they are not immediately obvious) and provide information on precautions to avoid them.
  • Adopt measures to enable him to be informed of the risks (e.g. recording safety related returns) and where necessary, enable him to withdraw unsafe products from the distribution chain.

Such measures may include:

  • Provision of appropriate marking of product with the name and address of the producer, serial and model numbers
  • Sample testing of products on the market
  • Investigation and recording of complaints
  • Keeping distributors informed of monitoring work and the results

Under the Tobacco and Related Products Regulations there is an obligation for all producers to ensure that products are both compliant with the laws laid down in the regulations, and that certain products are declared and/or tested and duly notified to MHRA through a specified IT system.

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